Study of Radiotracer [18F]Fluortriopride ([18F]FTP) by PET/CT
Status: | Active, not recruiting |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/22/2019 |
Start Date: | January 2015 |
End Date: | July 2020 |
Phase I Pilot Study of Biodistribution, Metabolism and Excretion of Novel Radiotracer [18F]Fluotriopride ([18F]FTP) by PET/CT
In this phase 1 pilot study, positron emission tomography (PET/CT) imaging will be used to
determine the biodistribution, metabolism and excretion of a novel radiotracer
[18F]Fluortriopride ([18F]FTP).
determine the biodistribution, metabolism and excretion of a novel radiotracer
[18F]Fluortriopride ([18F]FTP).
[18F]FTP is a novel radioactive tracer that has shown potential in labeling dopamine D3
receptors through PET/CT imaging. This is a phase 1 study design meant to evaluate safety,
biodistribution and brain uptake of [18F]FTP in healthy volunteers.
receptors through PET/CT imaging. This is a phase 1 study design meant to evaluate safety,
biodistribution and brain uptake of [18F]FTP in healthy volunteers.
Inclusion Criteria:
1. Participants will be ≥ 18 years of age
2. "Healthy volunteer" is defined as being in good general health in the opinion of an
investigator (controlled diabetes, controlled hypertension or other well controlled
chronic medical conditions may be allowed at the discretion of an investigator if they
do not believe they will increase patient risk or interfere with the collection of
imaging data, specific excluded conditions are described under exclusion criteria)
3. Participants must be informed of the investigational nature of this study and provide
written informed consent in accordance with institutional and federal guidelines prior
to study-specific procedures.
Exclusion Criteria:
1. Females who are pregnant at the time of screening will not be eligible for this study,
urine or blood pregnancy test will be performed in women of child-bearing potential at
screening.
2. Body Mass Index (BMI) > 35
3. Sustained uncontrolled hypertension (Systolic blood pressure greater than 160 mm Hg
and/or diastolic blood pressure greater than 110 mm Hg) at screening intake session.
If either of the pressure values is above the stated limits on the initial assessment,
blood pressure may be re-tested twice after initial assessment at five minute
intervals (for a total of 3 blood pressure assessments). The pressure elevation is
considered sustained if either the systolic or diastolic pressure values are outside
the stated limits for all three assessments, and the subject will be excluded from
study participation.
4. History of epilepsy or seizure disorder as assessed by medical record review and/or
self-reported
5. History of head trauma, that in the opinion of an investigator may interfere with the
uptake of [18F]FTP as assessed by medical record review and/or self-reported
6. History of Post-Traumatic Stress Disorder (PTSD), bipolar disorder, schizophrenia or
psychotic disorder as assessed by medical record review and/or self-reported
7. Use of dopaminergic CNS stimulants (prescription, over-the counter or recreational
drugs) within 30 days of screening intake visit , as assessed by review of health
history form and concomitant medication review at screening intake visit (from medical
record and/or self-reported) that are deemed by a physician investigator to have a
potential influence on the binding of [18F]FTP
8. Positive urine drug screen at the screening intake visit
9. Self-reported current alcohol consumption that exceeds greater than 25 drinks per week
10. Any current medical condition, illness, or disorder as assessed by medical record
review and/or self-reported that is considered by a physician investigator to be a
condition that could compromise participant safety or successful participation in the
study
11. Unwilling or unable to provide informed consent
We found this trial at
1
site
3400 Spruce St
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
(215) 662-4000
Phone: 215-898-4346
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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